Xylem Analytics Germany Sales GmbH & Co. KG

https://www.xylemanalytics.com

Oct 5, 2026

How audit-ready are your measurement data - really?

Data integrity deficiencies appear in roughly 60 to 80 percent of pharmaceutical GMP warning letters. The FDA issued 303 drug warning letters in fiscal year 2025 - a 59 percent increase from the year before. The most common findings: disabled audit trails, shared logins, backdated records and missing audit trail reviews. Audit trails are often configured correctly at a technical level but not reviewed routinely - and the FDA treats that as a failure regardless of the trail's technical configuration.

In the pharmaceutical, biotechnology and medical technology sectors, compliance with GxP standards is not only a legal obligation but a decisive competitive advantage. It guarantees safety, quality and seamless traceability of processes and data.

The MultiLab® Pro IDS from Xylem is fully compliant with 21 CFR Part 11, GMP and GLP - and implements these requirements directly in the device.

Secure access: User roles, password policies and authentication systems protect against unauthorized access. No shared logins, no gray areas.

Audit trail: Every change and access is logged and traceable - who changed what, and when. The original value is preserved. The audit trail is not only technically present but genuinely reviewable.

Tamper-proof data storage: Electronic data is stored in a tamper-proof manner. Manipulation or deletion without traceability is excluded.

Electronic signatures: Handwritten signatures are replaced by electronic ones with full legal validity. Approvals are legally documented.

Reproducibility through standardized processes: Validated methods, automated documentation and standardized processes ensure consistent, reproducible results. Predefined methods including QSC calibration and FDO® Check are integrated. Automatic documentation secures consistently high standards.

Compliance is not an add-on feature in the MultiLab® Pro IDS - it is an integral part of the device. So labs have no open questions at the next inspection.

👉 Learn more about GxP compliance with the MultiLab® Pro IDS